Acute Liver Failure

Acute liver failure and acute liver injury observational study

Enrollment status: OPEN

A multi-center NIH study initiated in 1997 is looking at acute liver failure and severe acute liver injury in adults. The aim of this study is to gather prospective demographic and clinical data on patients with acute liver failure and acute liver injury with varying etiologies.

Inclusion criteria

• INR ≥ 1.5 with or without encephalopathy due to any cause

Informed consent may be obtained from a family member.

Blood and urine samples, clinical data, and survival will be obtained × 7 days.

Contacts for referrals or questions:

Principal investigator: Robert Fontana, MD rfontana@med.umich.edu

• Kendall Dubois, BS (734) 936-4886 kendalld@med.umich.edu

ALF-MBT: ¹³C-methacetin breath test for the prediction of outcome in acute liver failure

Enrollment status: OPEN

To assess the safety and utility of the ¹³C-methacetin breath test system in predicting survival in adult ALF patients.

Inclusion criteria

• Adult men or women
• Severe acute liver injury
• INR ≥ 1.5
• Presence of any degree of hepatic encephalopathy
• Duration of illness < 26 weeks
• Enrolled in ALFSG registry

Informed consent may be obtained from a family member.

Test will be performed on Day 1, 2, 3, 5, and 7 of study enrollment.

Contacts for referrals or questions:

Principal investigator: Robert Fontana, MD rfontana@med.umich.edu

• Theodora Siettas, BS (734) 936-4886 tsiettas@med.umich.edu

ROTEM: Potential use of rotational thromboelastometry to explore hemostatic abnormalities in patients with acute liver failure

Enrollment status: OPEN

The goal of this study is prove that ROTEM is a reliable tool to help doctors identify subjects with acute liver failure who will or will not have a greater tendency to bleed.

Inclusion criteria

• Enrolled in the ALFSG registry
• Presence of any degree of hepatic encephalopathy
• INR ≥ 1.5 with or without encephalopathy due to any cause

Informed consent may be obtained from a family member.

Blood will be obtained × 5 days.

Contacts for referrals or questions:

Principal investigator: Robert Fontana, MD rfontana@med.umich.edu

• Theodora Siettas, BS (734) 936-4886 tsiettas@med.umich.edu

STOP-ALF: A phase 2a study to evaluate the safety and tolerability of OCR-002 (ornithine phenylacetate) in the treatment of patients with acute liver failure/severe acute liver injury due to acetaminophen overdose

Enrollment status: CLOSED, follow-up continuing

The goal of the STOP-ALF protocol is to evaluate the safety and tolerability of OCR-002 (ornithine phenylacetate) to reduce venous ammonia levels in patients with ALF or severe liver injury due to acetaminophen overdose.

Inclusion criteria

• ALF or ALI (INR ≥ 1.5) secondary to acetaminophen overdose
• Venous ammonia ≥ 60 µmol/L

Study design

• Continuous infusion of OCR-002 (ornithine phenylacetate) for 5 days
• Collection of blood samples, urine, and EKGs throughout the study
• Follow-up visit at 1 month (participants will receive $30 for participation in the follow-up visit)

Contacts for referrals or questions:

Principal investigator: Robert Fontana, MD rfontana@med.umich.edu

• Kendall Dubois, BS (734) 936-4886 kendalld@med.umich.edu